The Effect of Attention on Fixation Stability During Dynamic Fixation Testing in Stargardt Disease
American Journal of Ophthalmology
Purpose: Sensitive, reproducible visual function biomarkers are necessary to evaluate the efficacy of emerging treatments for Stargardt disease type 1 in clinical trials. We previously demonstrated that fixation stability may serve as a secondary outcome parameter for visual function loss. However, the test duration and protocol have an unknown effect on the assessment of fixation stability. Here, we hypothesize that separate fixation testing with a single target is different from combined fixation testing using the same target with simultaneous perimetry testing.
Design: International, multicenter, prospective, cross-sectional study.
Methods: Microperimetry data from the international, multicenter, prospective Progression of Atrophy Secondary to Stargardt Disease (ProgStar, NCT01977846) study were analyzed. Patients underwent various types of fixation testing including static testing and dynamic testing, and a duration-corrected dynamic test was generated (30sEpoch).
Results: A total of 437 eyes from 235 patients were included (mean age, 33.8 ± 15.1 years; 55.3% female). The mean 1SD-BCEA (bivariate contour ellipse area), which is the smallest ellipse encompassing 1 standard deviation of all fixation events, was smaller for the static fixation test compared to the 30sEpoch (4.5 ± 6.9 deg2 vs 5.3 ± 7.0 deg2; P = .02) and the number of points within both the 2-degree and 4-degree circles was larger (P < .0001).
Conclusions: Our results suggest that differences in static and dynamic assessment of fixation stability are dependent not only on different test durations but also on the testing protocol of a single fixation target vs fixation target plus simultaneous perimetry testing and provide information on the conduct of fixation testing for clinical trials.
Schönbach EM, Strauss RW, Ibrahim MA, Janes JL, Cideciyan AV, Birch DG, Sunness JS, Zrenner E, Ip MS, Kong X, Sadda SR, Scholl HPN; ProgStar Study Group. The Effect of Attention on Fixation Stability During Dynamic Fixation Testing in Stargardt Disease. Am J Ophthalmol. 2020 Sep;217:305-316. doi: 10.1016/j.ajo.2020.05.002. Epub 2020 May 11. PMID: 32422174.